FDA 510(k)

TrailBlazer Angled Support Catheter

K-Nummer: K162384 · 2016-09-22

AntragstellerMedtronic Vascular, Inc.(Formerly Ev3 Inc.)

Entscheidungsdatum2016-09-22

ProduktcodeDQY

BeratungsausschussCV

EntscheidungSubstantially Equivalent

Produktübersicht

TrailBlazer Angled Support Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular, Inc.(Formerly Ev3 Inc.). It received FDA 510(k) clearance on 2016-09-22 under 510(k) number K162384. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the TrailBlazer Angled Support Catheter?

TrailBlazer Angled Support Catheter is a medical device that received FDA 510(k) clearance on 2016-09-22. The listed applicant is Medtronic Vascular, Inc.(Formerly Ev3 Inc.). The 510(k) number is K162384.

When did TrailBlazer Angled Support Catheter receive FDA 510(k) clearance?

TrailBlazer Angled Support Catheter received FDA 510(k) clearance on 2016-09-22, under 510(k) number K162384.

Who is the listed applicant for TrailBlazer Angled Support Catheter?

The FDA 510(k) record lists Medtronic Vascular, Inc.(Formerly Ev3 Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TrailBlazer Angled Support Catheter?

The FDA product code for TrailBlazer Angled Support Catheter is DQY.

Zugehörige klinische Studien

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Verwandte Geräte (Code: DQY)

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLC K262240SSPC NXT DeliverkatheterCenterPoint Systems, LLC K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC K261825Amplatzer TorqVue LP Lieferungssystem; Amplatzer TorqVue LP KatheterAbbott

Offizielle Quelle

In der FDA-Datenbank anzeigen →

Daten aus der FDA Open API. Für die aktuellsten und verbindlichen Informationen konsultieren Sie bitte stets den offiziellen Datensatz.